The present invention relates to a medicament injection kit for injecting a therapeutic medicament into a tissue in a living body. More specifically, the present invention relates to a medicament injection kit for injecting a therapeutic medicament, which is used for introducing a gene into a tissue in a living body without using viral vectors.
Since around 1990, in the United States, there has been proposed the gene therapy for treating diseases such as cancer by introducing a gene into cells in a living body. In the gene therapy, it is most important to efficiently introduce the intended gene into the target cells. The methods for introducing a gene into cells are generally classified into two types: the type in which viral vectors are used (see, for example, Heikkila P. et al., (England), Gene Therapy, 1996, Vol. 3, pp. 21-27), and the type in which viral vectors are not used (see, for example, U.S. Pat. Nos. 4,897,355 and 5,334,761).
The method using viral vectors has been used most widely until recently, because the method has been considered to be the most effective from the viewpoints of high introduction efficiency. In the efficiency of introduction of a gene into cells, the method using viral vectors is much higher than the other methods in which viral vectors are not used; thus, the method using viral vectors has been the most excellent in efficiency.
A typical one of the methods not using viral vectors is the liposome method, in which a chemically synthesized lipid is used. This method is high in safety, and has been developed to be very high in introduction efficiency ex vivo, particularly. Agents used in the liposome method can be synthesized inexpensively, and it is considered to be excellent introduction means suited to mass preparation.
Besides, only in the case of a muscle, there has also been practiced a method of plasmid direct injection. This method has been reported to be clinically effective for angiogenesis in the heart, particularly.
However, the gene introduction method using viral vectors involves a problem as to safety, and may be attended by a severe side effect; therefore, a new protocol for this method is not approved at present. On the other hand, the gene introduction methods not using a viral vectors are unsatisfactory in introduction efficiency in vivo, give small gene expression amounts in cells and are limited in therapeutic effect, though the method are very high transfection efficiency ex vivo. Particularly, the method using a naked plasmid is low in the efficiency of introduction into cells and is considered to be difficult to put into practical use, though the method is extremely high in safety.